Last updated on emc: 29 Apr 2020

What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet.
The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD.
For further information call emc accessibility on 0800 198 5000.
The product code(s) for this leaflet is: PL00427/0162.

Ramipril 2.5mg/5ml Oral Solution

Package Leaflet: Information for the User

Ramipril 2.5mg/5ml Oral Solution

Ramipril

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Ramipril Oral Solution is and what it is used for
2. What you need to know before you take Ramipril Oral Solution
3. How to take Ramipril Oral Solution
4. Possible side effects
5. How to store Ramipril Oral Solution
6. Contents of the pack and other information

1. What Ramipril Oral Solution is and what it is used for

The name of your medicine is Ramipril 2.5mg/5ml Oral Solution (called Ramipril in this leaflet). Ramipril belongs to a group of medicines called ACE inhibitors (Angiotensin Converting Enzyme inhibitors).

Ramipril works by:

Decreasing your body’s production of substances that could raise your blood pressure

Making your blood vessels relax and widen

Making it easier for your heart to pump blood around your body.

Ramipril can be used:

To treat high blood pressure (hypertension)

To reduce the risk of you having a heart attack or stroke

To reduce the risk or delay the worsening of kidney problems (whether or not you have diabetes)

To treat your heart when it cannot pump enough blood to the rest of your body (heart failure)

If you are allergic (hypersensitive) to ramipril, any other ACE inhibitor medicine or any of the other ingredients of Ramipril listed in section 6. Signs of an allergic reaction may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue

If you have ever had a serious allergic reaction called “angioedema.” The signs include itching, hives (urticaria), red marks on the hands, feet and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing

If you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling under the skin in an area such as the throat) is increased

If you are having dialysis or any other type of blood filtration. Depending on the machine that is used, Ramipril may not be suitable for you

If you have kidney problems where the blood supply to your kidneys is reduced (renal artery stenosis)

During the last 6 months of pregnancy (see section below on "Pregnancy and breast-feeding")

If your blood pressure is abnormally low or unstable. Your doctor will need to make this assessment

If you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

Do not take Ramipril if any of the above apply to you. If you are not sure, talk to your doctor before taking Ramipril.

If you have lost a lot of body salts or fluids (through being sick (vomiting), having diarrhoea, sweating more than usual, being on a low salt diet, taking diuretics (water tablets) for a long time or having had dialysis)

If you are going to have treatment to reduce your allergy to bee or wasp stings (desensitization)

If you are going to receive an anaesthetic. This may be given for an operation or any dental work. You may need to stop your Ramipril treatment one day beforehand; ask your doctor for advice

If you have high amounts of potassium in your blood (shown in blood test results)

If you are taking medicines or have conditions which may decrease sodium levels in your blood. Your doctor may carry out regular blood tests, particularly for checking the levels of sodium in your blood especially if you are elderly

If you are taking any of the following medicines, the risk of angioedema may be increased:

If you have a collagen vascular disease such as scleroderma or systemic lupus erythematosus

You must tell your doctor if you think that you are (or might become) pregnant. Ramipril is not recommended in the first 3 months of pregnancy and may cause serious harm to your baby after 3 months of pregnancy (see section below on "Pregnancy and breast-feeding")

If you are taking any of the following medicines used to treat high blood pressure:

an angiotensin II receptor blocker (ARBs) (also known as sartans - for example valsartan, telmisartan, irbesartan), in particular if you have diabetes - related kidney problems

See also information under the heading "Do not take Ramipril Oral Solution".

Children and adolescents

Ramipril is not recommended for use in children and adolescents below 18 years of age because safety and efficacy of Ramipril in children has not yet been established.

If any of the above apply to you (or you are not sure), talk to your doctor before taking Ramipril.

Other medicines and Ramipril Oral Solution

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription (including herbal medicines). This is because Ramipril can affect the way some other medicines work. Also some medicines can affect the way Ramipril works.

Please tell your doctor if you are taking any of the following medicines. They can make Ramipril work less well:

Medicines used to relieve pain and inflammation (e.g. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen or indomethacin and aspirin)

Medicines used for the treatment of low blood pressure, shock, cardiac failure, asthma or allergies such as ephedrine, noradrenaline or adrenaline. Your doctor will need to check your blood pressure.

Please tell your doctor if you are taking any of the following medicines. They can increase the chance of getting side effects if you take them with Ramipril:

Sacubitril/valsartan - used for treating a type of long term (chronic) heart failure in adults (see section 2 'Do not take Ramipril Oral Solution')

Medicines used to relieve pain and inflammation (e.g. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen or indomethacin and aspirin)

Medicines for cancer (chemotherapy)

Medicines to stop the rejection of organs after a transplant such as ciclosporin

Diuretics (water tablets) such as furosemide

Potassium supplements (including salt substitutes), potassium-sparing diuretics and other medicines that can increase the amount of potassium in your blood (e.g. trimethoprim and co-trimoxazole for infections caused by bacteria; ciclosporin, an immunosuppressant medicine used to prevent organ transplant rejection; and heparin, a medicine used to thin blood to prevent clots)

Steroid medicines for inflammation such as prednisolone

Allopurinol (used to lower the uric acid in your blood)

Procainamide (for heart rhythm problems)

Temsirolimus (for cancer)

Sirolimus, everolimus (for prevention of graft rejection)

Vildagliptin (used for treating type 2 diabetes)

Racecadotril (used against diarrhoea).

Please tell your doctor if you are taking any of the following medicines. They may be affected by Ramipril:

Your doctor may need to change your dose and/or to take other precautions:

If you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also information under the headings "Do not take Ramipril Oral Solution" and "Warnings and precautions").

If any of the above apply to you (or you are not sure), talk to your doctor before taking Ramipril.

Ramipril Oral Solution with food and alcohol

Drinking alcohol with Ramipril may make you feel dizzy or light-headed. If you are concerned about how much you can drink while you are taking Ramipril, discuss this with your doctor as medicines used to reduce blood pressure and alcohol can have additive effects.

Ramipril may be taken with or without food.

Pregnancy and breast-feeding

Pregnancy

You must tell your doctor if you think that you are (or might become) pregnant.

You should not take Ramipril in the first 12 weeks of pregnancy, and you must not take them at all after the 13th week as their use during pregnancy may possibly be harmful to the baby.

If you become pregnant while on Ramipril, tell your doctor immediately. A switch to a suitable alternative treatment should be carried out in advance of a planned pregnancy.

Breast-feeding

You should not take Ramipril if you are breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

You may feel dizzy while taking Ramipril. This is more likely to happen when you start taking Ramipril or start taking a higher dose. If this happens, do not drive or use any tools or machines.

ethyl and butyl parahydroxybenzoates. These may cause an allergic reaction. This allergy may happen some time after starting the medicine

sodium. This medicine contains less than 1mmol sodium (23mg) per ml, that is to say essentially 'sodium-free'

propylene glycol. This medicine contains 50mg propylene glycol in each ml. If you are pregnant or breast-feeding or if you suffer from a liver or kidney disease, do not take this medicine unless recommended by your doctor. Your doctor may carry out extra checks while you are taking this medicine.

3. How to take Ramipril Oral Solution

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Taking this medicine

This medicine contains 2.5 milligram (2.5mg) of Ramipril in each 5 millilitre (5ml) of solution.

Take this medicine at the same time of the day each day.

Take this medicine by mouth.

This medicine can also be administered via nasogastric (NG) or percutaneous endoscopic gastrostomy (PEG) tubes.

Do not use with a tube which is made of latex.

Instructions for use via NG or PEG tube:

1. ensure the tube is clear before taking the medicine
2. flush the tube with 5ml of water
3. administer the medicine into the tube, with a suitable measuring device
4. flush the tube again with 5ml of water.

How much to take

Treatment of high blood pressure

The usual starting dose is 1.25mg (2.5ml) or 2.5mg (5ml) once daily.

Your doctor will adjust the amount you take until your blood pressure is controlled.

The maximum dose is 10mg (20ml) once daily.

If you are already taking diuretics (water tablets), your doctor may stop or reduce the amount of the diuretic you take before beginning treatment with Ramipril.

To reduce the risk of you having a heart attack or stroke

The usual starting dose is 2.5mg (5ml) once daily.

Your doctor may then decide to increase the amount you take.

The usual dose is 10mg (20ml) once daily.

Treatment to reduce or delay the worsening of kidney problems

You may be started on a dose of 1.25mg (2.5ml) or 2.5mg (5ml) once daily.

Your doctor will adjust the amount you are taking.

The usual dose is 5mg (10ml) or 10mg (20ml) once daily.

Treatment of heart failure

The usual starting dose is 1.25mg (2.5ml) once daily.

Your doctor will adjust the amount you take.

The maximum dose is 10mg (20ml) daily. Two administrations per day are preferable.

The usual dose is 10mg (20ml) daily. Two administrations per day are preferable.

Elderly

Your doctor will reduce the initial dose and adjust your treatment more slowly.

If you take more Ramipril Oral Solution than you should

Tell a doctor or go to the nearest hospital casualty department straight away. Do not drive to the hospital, get somebody else to take you or call for an ambulance. Take the medicine pack with you. This is so the doctor knows what you have taken.

If you forget to take Ramipril Oral Solution

If you miss a dose, take your normal dose when it is next due.

Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Ramipril and see a doctor straight away, if you notice any of the following serious side effects – you may need urgent medical treatment:

Swelling of the face, lips or throat which make it difficult to swallow or breathe, as well as itching and rashes. This could be a sign of a severe allergic reaction to Ramipril

Bruising more easily, bleeding for longer than normal, any sign of bleeding (e.g. bleeding from the gums), purple spots, blotching on the skin or getting infections more easily than usual, sore throat and fever, feeling tired, faint, dizzy or having pale skin. These can be signs of blood or bone marrow problems

Severe stomach pain which may reach through to your back. This could be a sign of pancreatitis (inflammation of the pancreas)

Fever, chills, tiredness, loss of appetite, stomach pain, feeling sick, yellowing of your skin or eyes (jaundice). These can be signs of liver problems such as hepatitis (inflammation of the liver) or liver damage.

Other side effects include:

Please tell your doctor if any of the following gets serious or lasts longer than a few days.

Common (affects less than 1 in 10 people):

Headache or feeling tired

Feeling dizzy. This is more likely to happen when you start taking Ramipril or start taking a higher dose

A swelling in your gut called “intestinal angioedema” presenting with symptoms like abdominal pain, vomiting and diarrhoea

Heartburn, constipation or dry mouth

Passing more water (urine) than usual over the day

Sweating more than usual

Loss or decrease of appetite (anorexia)

Increased or irregular heart beats

Swollen arms and legs. This may be a sign of your body holding onto more water than usual

Flushing

Blurred vision

Pain in your joints

Fever

Sexual inability in men, reduced sexual desire in men or women

An increased number of certain white blood cells (eosinophilia) found during a blood test

Blood tests showing changes in the way your liver, pancreas or kidneys are working.

Rare (affects less than 1 in 1,000 people):

Feeling shaky or confused

Red and swollen tongue

Severe flaking or peeling skin, itchy, lumpy rash

Nail problems (e.g. loosening or separation of a nail from its bed)

Skin rash or bruising

Blotches on your skin and cold extremities

Red, itchy, swollen or watery eyes

Disturbed hearing or ringing in your ears

Feeling weak

Blood tests showing a decrease in the number of red blood cells, white blood cells or platelets or in the amount of haemoglobin.

Very rare (affects less than 1 in 10,000 people):

Being more sensitive to the sun than usual.

Other side effects reported:

Please tell your doctor if any of the following gets serious or lasts longer than a few days.

Difficulty concentrating

Swollen mouth

Blood tests showing too few blood cells in your blood

Blood tests showing less sodium than usual in your blood

Concentrated urine (dark in colour), feel or are sick, have muscle cramps, confusion and fits which may be due to inappropriate ADH (anti-diuretic hormone) secretion. If you have these symptoms contact your doctor as soon as possible

Fingers and toes changing colour when you are cold and then tingling or feeling painful when you warm up (Raynaud's phenomenon)

Breast enlargement in men

Slowed or impaired reactions

Burning sensation

Change in the way things smell

Hair loss.

If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Ramipril Oral Solution

Keep this medicine out of the sight and reach of children.

Store in a refrigerator (2-8°C).

Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.

Once you open the bottle, it can only be used for 1 month. Write the date you open the bottle on the label.

Do not use this medicine if you notice anything wrong with the medicine. Talk to your pharmacist.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Ramipril Oral Solution contains

The active substance is ramipril. This medicine contains 2.5mg of ramipril in each 5ml of solution.